The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.
Study GS-US-320-0108 is a multi-center clinical trial, planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort was registered separately (NCT02836236) on ClinicalTrials.gov as the China cohort will not be part of the main study analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
426
25 mg tablet administered orally once daily
300 mg tablet administered orally once daily
Tablet administered orally once daily
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL
The primary efficacy endpoint was determined by the achievement of HBV DNA \< 29 IU/mL at Week 48.
Time frame: Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline, Week 48
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Tablet administered orally once daily
Asian Pacific Liver Center
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Research and Education, Inc.
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Silicon Valley Research Institute
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University of Miami
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Digestive Disease Associates, PA
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ID Care
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...and 95 more locations